Ireland
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Recruiting Phase 1

A Study to Evaluate the Safety, Tolerability, and Drug Levels of BMS-986521 in Healthy Participants.

NCT07283263 · tracked via the Priya Life Science USA tracker
Phase
Phase 1
Started
2025-12-23
Last updated
2026-01-07

Condition(s) studied

Healthy Volunteers

Investigational drug(s) / intervention(s)

BMS-985521Placebo

BMS-985521: Specified dose on specified days.

Placebo: Specified dose on specified days

Study summary

The purpose of this study is to evaluate the safety, tolerability, and drug levels of BMS-986521 following single and multiple ascending doses of BMS-986521 in healthy adult participants, and to evaluate potential food effects on BMS-986521 exposure.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
Accepted
Inclusion Criteria: * Participants must be healthy males and females (assigned at birth) who are not of childbearing potential, with no clinically significant abnormalities in medical history, physical exam, ECG, or lab tests. * Participants must have a body mass index (BMI) between 18 and 32 kg/m² (inclusive) and body weight of at least 50 kg. * For Part B/Cohort 11 only: participants with stable cardiovascular conditions may be included if deemed suitable by the investigator. Exclusion Criteria: * Participants must not have any significant medical condition or history (renal, hepatic, hematologic, GI, endocrine, pulmonary, neurologic, or immunologic) that may affect drug absorption, distribution, metabolism, or excretion (ADME), or pose a risk to the participant. * Participants must not have a history of rhabdomyolysis, cancer (except certain cured skin or cervical cancers), hematologic malignancy, or myelodysplastic syndrome. * Participants must not have recent or current significant GI disease, major surgery, or medical interventions affecting ADME (except appendectomy or cholecystectomy). * Participants must not have had a blood transfusion within 4 weeks or have an inability to tolerate oral medication or venous access. * Other protocol defined inclusion/exclusion criteria apply.

Primary outcome measure(s)

  • Number of participants with treatment-emergent adverse events (AEs) — Up to approximately Day 40
  • Number of participants with treatment-emergent serious adverse events (SAEs) — Up to approximately Day 40
  • Number of participants with Treatment-emergent suicidal ideation and behavior as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) — Up to approximately Day 14

Trial sites (1)

FacilityCityRegionStatus
CenExel ACT (Formerly Anaheim Clinical Trials; LLC) Anaheim California Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07283263 on ClinicalTrials.gov ↗ ← All trials in the USA